Furosemide Treatment Before Blood Transfusion in Patients With Systolic Dysfunction

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified October 2012 by Tel-Aviv Sourasky Medical Center
Sponsor:
Information provided by (Responsible Party):
Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier:
NCT01705470
First received: October 9, 2012
Last updated: October 11, 2012
Last verified: October 2012
  Purpose

The study Objective is to assess the clinical and echocardiographic changes of patients with systolic dysfunction receiving blood transfusion, with or without prior treatment with furosemide


Condition Intervention
Anemia Treatment Among Patients Suffering From Left Ventricular Systolic Dysfunction
Drug: furosemide
Drug: placebo normal saline

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Tel-Aviv Sourasky Medical Center:

Primary Outcome Measures:
  • Diastolic echocardiographic changes following blood transfusion, with or without Furosemide treatment [ Time Frame: Within 4 hours from receiving the blood transfusion ] [ Designated as safety issue: Yes ]
    Diastolic echocardiographic variables, including Ea, E to Ea ratio, E to A ratio, and Pulmonary vein flow velocities, following blood transfusion, with or without Furosemide treatment


Secondary Outcome Measures:
  • clinical outcome following blood transfusion, with or without Furosemide treatment [ Time Frame: Within 4 hours from receiving the blood transfusion ] [ Designated as safety issue: Yes ]
    clinical outcome variables following blood transfusion, with or without Furosemide treatment, including the respiratory rate and oxygen saturation


Estimated Enrollment: 30
Study Start Date: October 2012
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: arm1
will receive 60 mg (6 ml) of intra-venous furosemide before administration of the blood transfusion (250-300 ml of packed cells).
Drug: furosemide
Experimental: arm2
will receive 6 ml of normal saline (NaCl 0.9%) before administration of the blood transfusion (250-300 ml of packed cells).
Drug: placebo normal saline

Detailed Description:

More than 4 million patients receive a blood transfusion each year in the United States, many of them suffer from congestive heart failure. The reported prevalence of anemia in CHF is unknown, ranges widely from 4% to 70%, due to a lack of an established, consistent definition of anemia in CHF.

Treating CHF patients with furosemide prior to blood transfusion became a common practice, even though no randomize clinical trial had examine this issue. Nand et al. measured the pulmonary capillary wedge pressures in 20 adults with chronic severe anemia (Hg <6 mg/dl) and no systemic disease before and after transfusion of 700ml of whole blood. Ten of these patients were treated with furosemide (40 mg intra-venous) immediately prior the transfusion. The PCWP had increased significantly among patient who did not receive the furosemide and decreased by 3.75% among patients in the furosemide group, although this change was not was statistically significant. In another study, the same group of Nand et al. measured the PCWP among 40 chronic anemia patients receiving blood transfusion. None of the patients suffered from cardiopulmonary disease. The patients were randomly divided into 4 groups: the difference between the first 3 groups was the speed of the transfusion (2 ml/min, 5 ml/min and 10 ml/min). The fourth group patients were treated with 40 mg of furosemide before the transfusion was given in a rate of 5 ml/min. The PCWP increased significantly in the first 3 groups, with the rise being proportionately greater with faster transfusions (15.8, 20.9 and 32.2% in groups A, B and C, respectively). In the furosemide group, however, the PCWP decreased significantly by 21.7%.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject is over 18 years old.
  • Documented ejection function equal to or over 40% in prior tests
  • The treating physician decided to treat the patient with packed cell

Exclusion Criteria:

  • Known hypersensitivity to furosemide.
  • Calculated creatinine clearance over 20% (by MDRD)
  • Past adverse reaction to blood product.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier: NCT01705470     History of Changes
Other Study ID Numbers: SHERLOCK
Study First Received: October 9, 2012
Last Updated: October 11, 2012
Health Authority: Israel: Ethics Committee

Keywords provided by Tel-Aviv Sourasky Medical Center:
Furosemide
Anemia
LV dysfunction
blood transfusion

Additional relevant MeSH terms:
Anemia
Stress, Psychological
Ventricular Dysfunction, Left
Hematologic Diseases
Behavioral Symptoms
Ventricular Dysfunction
Heart Diseases
Cardiovascular Diseases
Furosemide
Sodium Potassium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 20, 2014